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A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

NCT04058158 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-26

Study results available
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Summary

This is a randomised Phase III, double-blind, multicentre, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and Soliris® in subjects with PNH.

Conditions

Interventions

DRUG

SB12 (proposed eculizumab biosimilar)

600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

DRUG

Soliris (eculizumab)

600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-07
Primary Completion
2021-09-21
Completion
2021-10-21

Countries

  • India
  • Malaysia
  • Mexico
  • Romania
  • South Korea
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04058158 on ClinicalTrials.gov